Adjustable gastroplastry ring comprising a grip tab

ABSTRACT

The invention relates to a gastroplasty ring formed by a flexible band ( 2 ) which comprises a first end part ( 5 ) and a second end part ( 6 ) and which is intended to be closed around the stomach toward its two end parts by a closure system in order to reduce the diameter of the opening of the stoma by forming a loop, the band comprising an adjustable-volume annular compression chamber ( 3 ) connected, at the first end part, by an adjusting catheter ( 7 ) to a device for adjusting the internal pressure of said chamber, so as to adjust its diametral expansion, the ring comprising at least one grab tab ( 11, 12, 13 ) which projects toward the outside of the loop to make it easier for the two end parts to be brought together and parted. 
     Gastric implant for treating obesity.

CROSS REFERENCE RELATED APPLICATIONS

This application is a national phase of PCT/FR01/01434 filed May 11,2001, which claims priority to French Application Serial No. 00/06329filed May 12, 2000.

TECHNICAL FIELD

The present invention relates to the technical field of surgicalimplants intended to treat obesity by implanting a flexible gastric bandintended to restrict the stomach of a patient, said gastric band beingequipped with an annular compression chamber, the volume of which isvariable and can be adjusted via an adjusting catheter connected to anadjusting and control device implanted in the body of the patient.

The present invention relates to a gastroplasty ring formed by aflexible band which comprises a first end part and a second end part andwhich is intended to be closed around the stomach essentially toward andby its two ends, using a closure system so as to reduce the diameter ofthe opening of the stoma by forming a loop, the band comprising anadjustable-volume annular compression chamber connected, at one of theend parts, by an adjusting catheter to a device for adjusting theinternal pressure of said chamber, so as to adjust its diametralexpansion.

PRIOR ART

In the case of patients suffering from extremely severe obesity (morbidobesity), that is to say in the case of patients whose weight exceedsthe ideal weight by at least fifty kilos, for example, it is absolutelyessential to treat these patients surgically in order not only to avoida series of health problems ensuing from this obesity, but also to avoidcertain and precipitate death of such patients.

Indeed, it is acknowledged that patients suffering from morbid obesitypresent a significantly reduced life expectancy, the reduction being byat least some ten to fifteen years, while at the same time creatingsignificant problems of physchological burden. Furthermore, a wholeseries of ancillary health phenomena are involved, having an impact onthe development of cardiovascular diseases, hypertension, diabetes, andsevere arthritis in particular.

It has been found that treatment based on a strict diet combined with aseries of physical exercises associated with a modification in behavior,particularly eating habits, were not very well suited to such cases ofmorbid obesity, even though such treatment methods are the most healthy.

This is why treatments for morbid obesity which are effective and remainso in the long-term, involve surgical treatment.

In general, a distinction is made between surgical treatment techniquesinvolving a lack of absorption of foodstuffs, that is to say ashortening of the conventional path of the food and of the digestivejuices, and techniques involving gastric restriction, reducing the sizeof the stomach.

Surgical techniques involving a lack of absorption are, for example,those involving a technique of bypassing the small intestine oralternatively those separating the passage of the foodstuffs relative tothe digestive juices. The surgical technique of bypassing may give riseto severe complications, which means that this technique is now usedonly very rarely. The surgical technique of separating the passage ofthe alimentary bolus relative to the digestive juices does not involveparticular complications, but entails a major surgical operationinvolving, in particular, a partial gastrectomy.

This is why the trend nowadays is to use surgical techniques employinggastric restriction to reduce the intake of food.

Such techniques conventionally involve the use of gastroplasty ringsimplanted around the stomach in order to reduce its size and thediameter of its passage (stoma).

Most of the known gastroplasty devices, and, for example, the onedescribed in U.S. Pat. No. 5,074,868, employ a flexible band made of anelastomeric material and intended to be implanted around the stomachthen tightened and closed into a loop of fixed diameter by a closuresystem. The body of the flexible band contains a variable-volumecompression chamber or cavity connected by an adjusting catheter to adevice for adjusting the internal pressure of the chamber so as to varythe inside diameter of the loop in order to modify or adjust thediameter of the stoma by injecting or extracting a volume of liquid intoor from the chamber. Such an operation of adjusting the inside diameterof the ring is performed using conventional control devices including aminiaturized unit implanted directly under the skin of the patient andequipped with a self-sealing membrane through which the doctor injectsor withdraws liquid using a syringe.

The closure system of U.S. Pat. No. 5,074,868 employs suturing, usingsutures, of the two parts of the flexible band of the ring.

Such a device is generally satisfactory but, like most of the knownsystems, suffers from disadvantages associated essentially with thedifficulty involved in any surgical operation likely to arise once thegastroplasty implant has been fitted. What has been found is that inspite of the possibility of, to a certain extent, altering the diameterof the ring without surgical intervention, using the miniaturized unitmentioned hereinabove, the fitting of such gastric implants may beaccompanied by phenomena of intolerance, for example accompanied byvomiting, associated with an excessive reduction in the diameter of thestoma, or alternatively with ineffective action of the implantassociated with an excessively large diameter of the stoma, oralternatively still, quite simply with discomfort or a local orgeneralized infection or inflammation.

This is why it is often necessary to perform a further surgicaloperation, either to make the patient more comfortable, or to modify orchange the gastroplasty ring already implanted. Such surgical operationsare particularly severe and in addition entail either a surgeon cuttingthe ring, or the cutting of the suture accompanied by a complete openingof the ring followed by its exchange and replacement.

Such operations are tricky to perform, are difficult for the patient totolerate, and are therefore expensive in that they entail destroying animplant and replacing it.

SUMMARY OF THE INVENTION

The object of the invention is therefore to propose a novel gastroplastyring making it possible to remedy the various drawbacks listed above andwhich is capable of making the ring easier to handle when the implant isbeing fitted and when the ring is being opened and closed again during afurther operation.

Another object of the invention is to propose a novel gastroplasty ringcapable simply and reliably of reversibly closing the loop that makes upthe ring while at the same time allowing easy unlocking of the endparts, doing so without entailing destruction of the implant.

Another object of the invention is to propose a novel gastroplasty ringcapable of offering a simple and reliable means of adapting the diameterof the ring to suit each given surgical situation.

Another object of the invention is to propose a novel gastroplasty ringcapable of exhibiting several implantation diameters.

Another object of the invention is to propose a novel gastroplasty ringmaking it possible to reduce the discomfort experienced by the patient,while at the same time being firmly held in place by the loop.

Another object of the invention is to propose a novel gastroplasty ringwhich is particularly easy to manufacture while at the same time havingexcellent overall mechanical strength.

The objects of the invention are achieved using a gastroplasty ringformed by a flexible band which comprises a first end part and a secondend part and which is intended to be closed around the stomach towardits two end parts by a closure system in order to reduce the diameter ofthe opening of the stoma by forming a loop, the band comprising anadjustable-volume annular compression chamber connected, at the firstend part, by an adjusting catheter to a device for adjusting theinternal pressure of said chamber, so as to adjust its diametralexpansion, characterized in that the ring comprises grab tabs whichproject toward the outside of the loop to make it easier for the two endparts to be brought together and parted.

BRIEF DESCRIPTION OF THE DRAWINGS

Further objects and advantages of the invention will become betterapparent from reading the appended description, and with the aid of thepurely illustrative and informative appended drawings, in which:

FIG. 1 illustrates, in a schematic perspective view, one embodiment of agastroplasty ring according to the invention, in the open position priorto its being implanted.

FIG. 2 illustrates, in a schematic perspective view, one embodiment of agastroplasty ring according to the invention, in the closed position.

FIG. 3 illustrates, in a view from above, the gastroplasty ring in FIG.2.

BEST EMBODIMENT OF THE INVENTION

FIGS. 1 and 2 illustrate a preferred embodiment of a gastroplasty ring 1according to the invention, formed by a flexible band 2 produced, forexample, by thermoforming, from an elastomeric material for surgicaluse, said band 2 defining, preferably essentially along its entirelength, an internal compression chamber 3 delimited by the walls 4 ofthe flexible band 2 and by a first end part 5 and a second end part 6.

In its position of implantation in the stomach of a patient, asillustrated in FIG. 2, the compression chamber 3 therefore forms anannular compression chamber.

As is well known in the prior art, the compression chamber 3 defines aclosed volume internal to the gastroplasty ring, which is intended toform a volume which is adjustable so that the diametral expansion of thering can be adjusted when the ring is in place so as to adapt it to suiteach given surgical situation.

In the conventional way, the diametral expansion of the gastroplastyring according to the invention is adjusted by an adjusting catheter 7formed by a tubular element made of elastomeric material extending oneof the free end parts, for example the first end part 5, of thecompression chamber 3 so as to connect said chamber to a device 8 foradjusting the internal pressure of said chamber.

As is well known to those skilled in the art, the adjusting device 8 maybe formed by a miniaturized unit 9 implanted under the skin of thepatient. The miniaturized unit 9 comprises, for example, a self-sealingupper membrane 10 intended to be pierced by a syringe so that a certainamount of fluid can be injected or withdrawn so as to vary the volume ofthe compression chamber 3, in order to adjust the volume of the chamberand thus obtain the desired inside diameter of the ring. As a devicesuch as this is well known to those skilled in the art, it willtherefore not be described further in detail.

The gastroplasty ring according to the invention also comprises aclosure system intended to close the gastroplasty ring in a loop aroundthe stomach and hold it in position.

According to an important feature of the invention, the ring furthercomprises at least one grab tab which projects outward from the loop tomake it easier for the two end parts to be brought together and partedwhen the ring is being closed and/or during a further operation in orderto adjust the ring, when unlocking it or alternatively when relockingit.

As depicted in the figures, the flexible band 2 has, near the first endpart 5 of the ring, at least one first grab tab 11.

As a preference, the second end part 6 comprises a second grab tab 12and, advantageously, it also bears a third grab tab 13.

Each of the grab tabs 11, 12, 13, is preferably essentially flat andextends between a first end which is secured to the walls of the ringand a second end which is free and can be grasped by gripping so as topositively move at least one of the end parts 5 and 6.

Also as a preference, the grab tabs are flexible so that they can moveout of the way when the ring is being introduced into the body of thepatient. They are of rectangular shape.

Each of the grab tabs extends tangentially to the walls 4 of the ring 1so that it is perpendicular to the plane of this ring and is of a smallsize with respect to the overall dimensions of the ring. In particular,the thickness of the tabs is slender with respect to their width and totheir length.

The grab tabs are formed integrally with the band and the walls of theend parts 5 and 6 or are attached and secured to these by any mechanicalor chemical means, such as by bonding or overmolding, for example, whilebeing made of a biocompatible elastomeric material.

In general, the grab tabs form protrusions which can be implanted at anypoint on the external surface or internal surface of the walls of theband and of the end parts, so as to be grabbed by the surgeon using anysurgical instrument such as forceps, for example, so as to make the ringeasier to handle, to lock and to unlock.

Also as a preference, the first grab tab 11 extends in the oppositedirection to the second end part 6. The second grab tab 12 extends inthe same direction as the first tab 11, while the third tab 13 is in theopposite direction to the other two tabs 11 and 12.

According to one feature of the invention, the closure system accordingto the invention comprises means for immobilizing and slackening thering, which means are carried by the adjusting catheter 7, thus makingit possible, starting from the position in which the ring isdiametrically immobilized, corresponding to the closed and loop-shapedposition as illustrated in FIG. 2, for it to be diametrically releasedfor a moment by a relative movement of the two end parts 6, 7 of thering, while at the same time, if so desired, forming a closed looparound the stomach. Advantageously, the immobilizing and slackeningmeans are reversible.

According to the invention, the immobilizing and slackening meanscomprise pneumatic means for closing and opening the ring, involving afluid, for example a gas or a liquid. Recourse to pneumatic means allowssimplified placement of the implant and simple control over its openingand closure.

Performing such a technical function makes it possible, in addition tothe simplicity of placement and of closure of the ring that it affords,to reduce the severity and impact of any repeat surgical interventionsfollowing the placement of an implant by avoiding having to cut throughand to destroy the gastroplasty ring fitted. A function such as thisallows the ring to be opened up easily using the first and third grabtabs 11, 13 and even the second tab, without destroying the loop of thering, possibly allows the ring to be left in place, and allowssubsequent re-locking using the second tab 12.

According to a preferred alternative form of the invention, asillustrated in FIGS. 1 and 2, the gastroplasty ring according to theinvention comprises a closure system, the reversible immobilizing andslackening means of which comprise at least one deformable zone 15 andan opening 16 formed in the wall 4 of the second end part 6 of the band2. The inflatable adjusting catheter 7 which is made of a biocompatibleelastomeric material, is intended to be slipped into the opening 16,when the ring is in the closed position, and also to act as a guidemeans.

The deformable zone 15 may form a protrusion if the pressure in theadjusting catheter 7 increases, said protrusion resting against thewalls 4 of the end part 6 of the band, inside the chamber 3, so as toimmobilize the ring in the closed position. The protrusion reverts toits shape at rest if the pressure inside the adjusting catheter 7returns to normal, so as to allow said catheter to slide and be guidedfreely in the opening 16, and so as to allow the loop to be slackened.

According to one particularly advantageous version of the invention, thereversible deformable zone 15 is formed by at least one zone of lesserstrength and, in its shape at rest, constitutes a zone of a shape thatconverges toward the second end part 6. It may, for example, be oftriangular shape in cross section, that is to say in a plane of sectionperpendicular to the plane of the ring.

Advantageously, the deformable zone 15 may be formed by a section of theadjusting catheter 7 having a hardness of the elastomeric material ofwhich the catheter is made, which is locally lower than the overallhardness of said catheter. In such a case, as the adjusting catheter 7is connected to the external adjusting device 8 for pressurizing using afluid (air or liquid), the zone 15 will tend to form a kind of balloonwith a diameter greater than the internal dimensions of the band, whichwill diametrically immobilize the ring. The pressurizing of the balloonoccurs before the band is pressurized, this being facilitated by theconvergent shape of the balloon.

Advantageously, the flexible band 2 is provided at one end part, and forexample at the second end part 6 opposite the first end part 5 which isextended via the adjusting catheter 7, with a hollow sleeve 20 extendingthe flexible band 2.

The hollow sleeve 20 also comprises the opening 16 which is formed inone of its faces, preferably an external face, so that the other end 5of the flexible band 2 can be inserted in said sleeve in the closedposition, the adjusting catheter 7 then passing through the opening 16(FIG. 2) to form the loop of the ring. Such a constructional arrangementmakes the withstand of the closure very reliable while at the same timeallowing the compression chamber 2 to extend around the entire perimeterfor clamping the stomach.

As a preference, the band 2 and the hollow sleeve 20 are of a crosssection of oblong shape to make it even easier still for the deformablezone 15 to become jammed when it is pressurized.

Advantageously, the flexible band 2, the compression chamber 3 and thehollow sleeve 20 form a one-piece unit made from one and the sameelastomeric plastic, the adjusting catheter 7 then being hot-welded on.

As a preference, the third grab tab 13 extends from the external surfaceof the sleeve, and partly over the opening 16 without, however, impedingthe passage of the catheter through this opening.

Advantageously, it is also possible for the deformable zone 15 to bemade with a thickness which differs from the thickness of the flexibleband 2 so as to obtain different fluid flow rates through each of theseelements. These different flow rates may also be obtained by differentshapes, the purpose of this being, for example, to deflate the flexibleband 2 before the deformable zone 15.

The end part 5 of the band 2 to which the adjusting catheter 7 isconnected is preferably of conical shape to make it easier to insertinto the hollow sleeve 20. The deformable zone 15 is situated insidethis conical shape.

Also as a preference, the adjusting catheter 7 has a limit stop 25 whichis situated at the end of the conical part, near the deformable zone 15,and which is intended to pass through the opening 16 of the hollowsleeve 20. After this limit stop has clipped into the opening 16, theprotrusion 15 may be immobilized by inflation.

These limit-stop means 25 consist for example of an excess of materialforming a lump facing toward the outside of the ring and which preventsunwanted unfastening of the ring. The clipping of these means also makesit possible to check that the catheter has been slipped far enough intothe opening 16 for the nominal ring diameter to be achieved, and alsomake sure that the protrusion is held in position immobilized in thehollow sleeve 20.

Furthermore, the adjusting catheter 7 is essentially rigid and is ofgreat length by comparison with the diameter of the ring, so as tofacilitate the operation of slipping and passing the catheter 7 into andthrough the opening 16. This also allows good placement of the band inthe desired position.

Producing a gastroplasty ring in one piece makes it possible to simplifythe method of manufacture of the ring and to obtain a ring whichpresents no risk of degradation over time.

During implantation, the ring according to the invention is set in placearound the stomach in the position illustrated in FIG. 1. As theadjusting device 8 is disconnected to start with, the surgeon slips theadjusting catheter 7 into the opening 16 and passes it through thelatter so as to insert the first end part 5 into the hollow sleeve 20(FIG. 1). The surgeon then brings the limit stop 25 into theimmobilizing position in the opening 16 using the second grab tab 12. Hemay then, using the adjusting and inflation device 8 connected to thesingle catheter 7, immobilize the ring in position. The surgeon thenadjusts the internal diameter of the ring by injecting or removing theappropriate amount of liquid through the catheter 7. It will be notedthat all of these operations are carried out using one single solitarycatheter 7.

In the event of a further surgical operation, it is possible, by virtueof the gastroplasty ring according to the invention, for the operationto be confined to a superficial external examination of the situation ofthe implant using celioscopy or laparoscopy, simply by opticalinspection using a camera. As appropriate, if the situation so demands,it is possible in a first instance, to unlock the catheter using simplecelioscopy. To do this, all that is required is for the catheter 7 to beput under depression, which leads to deflation of the band and to arelease of the balloon. All that is then required is for the two endparts 5 and 6 to be detached by action on the first and third lockingtabs 11, 13. The tabs therefore allow the limit stop 25 to be disengagedfrom the opening 16. The catheter may then be slid through the opening16. It is also possible to use the second grab tab 12 to extract thelimit stop and to open out the ring; the ring is then turned back onitself in the opposite direction to the first grab tab 11.

Such sliding is accompanied by a partial and momentary slackening of thering, without having to perform a serious operation on the patient.

It may be pointed out that the gastroplasty ring according to theinvention has grab tabs which, during unlocking, are manipulated inopposite directions so that the ring experiences essentially symmetricopposed forces. During unlocking, the ring therefore does not have atendency to move the part of the stomach around which it is placed.

It is then possible, also by a simple laparoscopic examination andoperation, to close the ring again and immobilize it in the closedposition in a very simple way, because the loop of the ring has neverbeen destroyed.

It will therefore be understood that the grab tabs 11 to 13 have thefunction of facilitating the locking of the ring and of making itpossible to unlock the ring without destroying this ring.

INDUSTRIAL APPLICABILITY

The invention finds its industrial application in the production and useof gastroplasty rings.

1. A gastroplasty ring configured to form a loop about a stomach havinga stoma, comprising: a flexible band having an outside surface and afirst end part and a second end part; a closure system for reducing adiameter of an opening of the stoma by forming a loop around the stomachtowards the first and the second end parts; and at least one grab tabprojecting from said outside surface of the loop, the at least one grabtab being configured to assist in joining and separating the two endparts, the at least one grab tab comprising: a first grab tab, disposedproximal to the first end part, configured for separating the first endpart from the second end part; and a second grab tab, spaced from thefirst and disposed at the second end part, configured for joining thefirst end part and the second end part together and further configuredto unlock the first end part from the second part; said grab tabs beingconfigured to be simultaneously manipulated in opposite directionsduring unlocking such that said ring experiences essentially symmetricopposed forces for providing partial and momentary slacking of the ring.2. The ring as claimed in claim 1, wherein the at least one grab tabfurther includes a third grab tab disposed on the second end part,thereby allowing the second end part to be parted from the first endpart.
 3. The ring as claimed in claim 2, wherein the grab tabs are ofessentially flat shape and extend between a first end which is securedto the ring and a second end which is free and can be grasped bygripping so as to positively move the ring end part on which the grabtab is mounted.
 4. The ring as claimed in claim 3, wherein the firstgrab tab faces in the opposite direction to the second end part, thesecond grab tab faces in the same direction as the first grab tab, andthe third grab tab faces away from the second grab tab.
 5. The ring asclaimed in claim 1, wherein the closure system further comprisespneumatic means for closing and opening the ring.
 6. The ring of claim1, further comprising: an adjustable-volume annular compression chamberbeing connected at the first end part to an adjusting catheter, theadjusting catheter configured for connection to a device for adjustingthe internal pressure of the chamber to adjust the diametrical expansionof the chamber.
 7. The ring as claimed in claim 6, wherein the closuresystem further comprises pneumatic means for closing and opening thering and the pneumatic means are carried by the adjusting catheter andinclude at least one deformable zone, an opening is formed in the wallof the second end part of the band, the adjusting catheter sliding inthe opening to form the loop of the ring, the deformable zone beingconfigured to form a protrusion in the event of an increase in thepressure in the catheter, said protrusion resting against the interiorwalls of the band so as to immobilize the ring in a closed position and,the deformable zone being capable of reverting to an original shape inthe event of a return to normal pressure, so as to allow the adjustingcatheter to slide freely and the loop to be slackened.
 8. The ring asclaimed in claim 7, wherein the deformable zone is a zone of lesserstrength formed on the adjusting catheter.
 9. The ring as claimed inclaim 7, wherein the second end part of the flexible band includes ahollow sleeve, said sleeve having the opening so that the first end partof the band can be inserted in the sleeve.
 10. The ring as claimed inclaim 9, wherein the first end part of the flexible band is ofconvergent shape and includes the deformable zone which is of triangularshape in cross section.
 11. The ring as claimed in claim 10, wherein thecross section of the band is of oblong shape.
 12. The ring as claimed inclaim 6, wherein the device for adjusting the internal pressure of thechamber is a compression/decompression device.
 13. The ring as claimedin claim 1, wherein the second end part of the flexible band includes ahollow sleeve, said sleeve having an opening for the first end part ofthe band can be inserted in to the hollow sleeve.
 14. A gastroplastydevice comprising: a flexible band having an outside surface and a firstend and a second end, the band configured to form a loop about a stomachby the first and second ends at a time when the band is in a closedposition; a system configured to releasably lock the first and secondend in the closed position and to unlock the first and second ends; andgrabbing means, projecting outwardly from said outside surface of theband, for manipulation by substantially opposing symmetric forces tomove the first and second ends into, and out of, the closed position;wherein the grabbing means comprises a first tab located proximate thefirst end and a second tab located proximate the second end, the firstand second tabs configured to be manipulated in opposite directions inorder to move the first and second ends into the closed position. 15.The device of claim 14, wherein the grabbing means further comprises athird tab proximate the second end and positioned between the first taband the second tab at a time when the band is in an open position. 16.The device of claim 15, wherein the first tab and the second tab areconfigured to be simultaneously manipulated by opposing forces to movethe first and second ends into the closed position, and the first taband the third tab are configured to be simultaneously manipulated byopposing forces in order to move the first and second ends out of theclosed position.
 17. The device of claim 14, wherein the second endincludes an opening in the surface and the first end includes adeformable portion configured for insertion into and through the openingat a time when the band is in the closed position.
 18. The device ofclaim 17, wherein the grabbing means comprises a first tab extendingfrom the surface that is proximate the first end and a second tabextending from the surface that is proximate the second end and, at atime when the band is in an open position, the opening is located on thesurface at a position between the first tab and the second tab.
 19. Thedevice of claim 18, wherein the grabbing means further comprises a thirdtab extending from the surface and adjacent to the opening and, at atime when the band is in the open position, the third tab is located onthe surface between the first tab and the second tab.
 20. The device ofclaim 17, wherein the grabbing means comprises a first tab proximate thefirst end, a second tab proximate the second end, and a third tabadjacent to the opening and: at a time when the band is in the closedposition, the opening is positioned on the outside of the ring in aportion of the surface between the first tab and the second tab, and thesecond tab is positioned between the first tab and the third tab; and ata time a time when the band is in an open position, the opening and thethird tab are positioned on the outside of the ring on a portion of thesurface between the first tab and the second tab.